ClearanceBrief
Recall Z-1767-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging

GE Healthcare LLC

SIGNA Premier systems

DateApr 2, 2026 (initiated Feb 27, 2026)
StatusOpen, Classified
ReasonWhole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Root causeNonconforming Material/Component
ActionOn 2/27/2026, correction notices were mailed to Director of Clinical/Radiology Risk Manager/Hospital Administrators informing them to take the following actions: 1) Ensure all potential servicing personnel in your facility are made aware of this safety notification and the recommended actions. 2) If the device requires service at the rear of the magnet, ensure that all servicing personnel are aware of this potential issue. 3) If servicing personnel have accessed the rear of the magnet with covers removed and identified that ferrous fittings are installed, do NOT attempt to remove or disconnec
Quantity41
DistributionWorldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K171128SIGNA Premier
Ge Medical Systems, LLC, Jul 14, 2017
K183231SIGNA Premier
Ge Medical Systems, LLC, Jan 18, 2019
K193282SIGNA Premier
Ge Healthcare (Ge Medical Systems, LLC), Apr 10, 2020